Analysis of Hyperthermia as an Adjunctive Treatment to Evidence-based Clinical Intervention in Subjects With Plantar Fasciitis: a Double-blind Randomized Clinical Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUniversity of Malaga

About this trial

This project aims to analyze the use of hyperthermia within a treatment protocol for plantar fasciitis, as well as to determine the difference between two and three sessions per week. Study participants will be divided into four intervention groups: the first will receive two sessions per week for a period of six months, while the second will receive three sessions per week for the same period. The treatment protocol will consist of therapeutic physical exercise focused on the foot muscles and stretching the plantar fascia and posterior chain, hyperthermia on the plantar fascia insertion area in the calcaneus and adjacent areas, and the use of an orthotic insole used for walking. The third and fourth intervention groups will receive the same treatment as mentioned above, but without hyperthermia. The third group will receive three sessions per week, while the second group will receive two sessions per week. Two different types of measurement variables will be used: objective variables will be used to measure local pain using an algometer, assess ankle joint range of motion, and use ultrasound imaging techniques. Subjective variables will also be used through validated questionnaires, which will address physical activity, perceived functional limitations in patients with lower limb pathologies, lower limb functional assessment, and a visual analogue scale for pain perception.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a diagnosis confirmed by performing an ultrasonography of Plantar Fascitis

Have not yet received physiotherapy treatment.

Disqualifiers

Have undergone surgery.

Those who refuse to participate in this study.

Patients with muscle atrophy due to plantar fasciitis.

Medical conditions that are contraindications for hyperthermia therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hyperthermia

    Radiation

    Hyperthermia will be applied for a period of 15 to 20 minutes in the area to be treated, maintaining a thermal sensation of gentle heat for the patient and accompanied by active-assisted or passive mobilization of the structures adjacent to the plantar fascia.

  • Physical Exercise

    Other intervention

    The therapeutic physical exercise focused on the flexor muscles of the foot will consist of 3 periods of isometric contraction of 15 seconds, with a rest period of 30 seconds, varying the number of repetitions from 3 to 5 depending on the patient's symptoms.

  • Stretching

    Other intervention

    The plantar fascia stretch will be performed with the patient in the supine position. Maximum dorsiflexion will be achieved, and the lower limb will be elevated with the knee extended as tolerated. This procedure will be performed three times in a row for 30 seconds, with a 1-minute rest between each stretch.

  • Orthopedic insole

    Other intervention

    Imposition of an orthopedic insole

Treatment groups

64 Participants
are divided into 4 treatment groups
Group A: Hyperthermia 2 times per weekExperimental treatment 4 interventions
Group B: Hyperthermia 3 times per weekExperimental treatment 4 interventions
Group C: Non-hyperthermia 2 times per weekExperimental treatment 3 interventions
Group D: Non-hyperthermia 3 times per weekExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

FOOT AND ANKLE ABILITY MEASURE (FAAM)

This instrument is based on the subjective assessment of physical function and activities of daily living in patients with musculoskeletal disorders of the lower limb. It consists of 29 items, divided into two subscales: activities of daily living (21 items) and sports activities (8 items). Each question can be scored on a scale from 4 (no difficulty) to 0 (total inability to perform the activity in question). The maximum score is 84 for the activities of daily living subscale and 32 for sports activities, representing full functionality. The Spanish version has been shown to be correctly translated from its original version and to present a correct structure, internal consistency, reliability, correlation between the total items and between items, and validity.

Time frame
Baseline and up to one year
2

LOWER EXTREMITY FUNCTIONAL SCALE (LEFS)

This questionnaire assesses perceived functionality in patients with a musculoskeletal problem in the lower limb. It consists of 20 questions, each of which is scored by the patient, ranging from 0 (extreme difficulty or inability to perform the activity) to 4 (no difficulty). The maximum score is 80 (no functional limitations), and the minimum score of 0 indicates extreme limitation. The Spanish adaptation has demonstrated similar values to the English version in the areas of internal consistency, reliability, structure, and error.

Time frame
Baseline and up to one year
3

International Physical Activity Questionnaire (IPAQ)

This instrument is designed to measure physical activity levels in an adult population and can serve as a reference for making recommendations regarding physical activity. It comes in two versions: the long version with 31 items (IPAQ-LF) and the short version with 9 items (IPAQ-SF). The short version, which will be used in this study as recommended by the authors, measures activity at four intensity levels, ranging from 1 (vigorous-intensity activity) to 4 (sedentary). It has very good reliability (r=0.8).

Time frame
Baseline and up to one year
4

Visual Analogue Scale (VAS)

It consists of an 11-point numerical scale, ranging from 0 (no pain) to 10 (maximum pain intensity), which serves as a quantification for measuring pain intensity. It has moderate to good reliability.

Time frame
Baseline and up to one year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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